Limits...
A Stability-Indicating HPLC-DAD Method for Determination of Ferulic Acid into Microparticles: Development, Validation, Forced Degradation, and Encapsulation Efficiency.

Nadal JM, Toledo Mda G, Pupo YM, Padilha de Paula J, Farago PV, Zanin SM - J Anal Methods Chem (2015)

Bottom Line: The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of quantification, limit of detection, accuracy, precision, and robustness provided suitable results regarding all parameters investigated.Precision (intraday and interday) was demonstrated by a relative standard deviation lower than 2.0%.In conclusion, the method is suitable to be applied to assay FA as bulk drug and into polymeric microparticles and can be used for studying its stability and degradation kinetics.

View Article: PubMed Central - PubMed

Affiliation: Postgraduate Program in Pharmaceutical Sciences, Department of Pharmacy, Federal University of Paraná, 632 Lothário Meissner Avenue, 80210-170 Curitiba, PR, Brazil.

ABSTRACT
A simple stability-indicating HPLC-DAD method was validated for the determination of ferulic acid (FA) in polymeric microparticles. Chromatographic conditions consisted of a RP C18 column (250 mm × 4.60 mm, 5 μm, 110 Å) using a mixture of methanol and water pH 3.0 (48 : 52 v/v) as mobile phase at a flow rate of 1.0 mL/min with UV detection at 320 nm. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of quantification, limit of detection, accuracy, precision, and robustness provided suitable results regarding all parameters investigated. The calibration curve was linear in the concentration range of 10.0-70.0 μg/mL with a correlation coefficient >0.999. Precision (intraday and interday) was demonstrated by a relative standard deviation lower than 2.0%. Accuracy was assessed by the recovery test of FA from polymeric microparticles (99.02% to 100.73%). Specificity showed no interference from the components of polymeric microparticles or from the degradation products derived from acidic, basic, and photolytic conditions. In conclusion, the method is suitable to be applied to assay FA as bulk drug and into polymeric microparticles and can be used for studying its stability and degradation kinetics.

No MeSH data available.


Related in: MedlinePlus

Plots of remaining FA concentration versus time for zero order (a), first order (b), and second order (c) equations.
© Copyright Policy - open-access
Related In: Results  -  Collection


getmorefigures.php?uid=PMC4446543&req=5

fig6: Plots of remaining FA concentration versus time for zero order (a), first order (b), and second order (c) equations.

Mentions: Regarding the presence of degradation products, forced degradation study showed different results depending on the stress condition used. After exposure to acid medium, approximately 29.37% of FA was degraded (Figure 5(a)) and the drug peak was recorded at 4.56 min. In alkaline condition, a FA degradation of 16.33% was observed and the drug peak was detected at 4.55 min (Figure 5(b)). No previous report was devoted to investigate the drug degradation using 0.1 M HCl and 0.1 M NaOH. Under photolytic conditions, decreases in FA concentration from methanol solution were observed (Figure 6). On the other side, the cuvette covered by aluminum paper showed no degradation after 6 h which indicates that no thermal degradation was involved in the photodegradation process. Moreover, no additional peak was verified in the chromatograms of the forced degradation study demonstrating that the degradation products were not detected using the optimized chromatographic conditions.


A Stability-Indicating HPLC-DAD Method for Determination of Ferulic Acid into Microparticles: Development, Validation, Forced Degradation, and Encapsulation Efficiency.

Nadal JM, Toledo Mda G, Pupo YM, Padilha de Paula J, Farago PV, Zanin SM - J Anal Methods Chem (2015)

Plots of remaining FA concentration versus time for zero order (a), first order (b), and second order (c) equations.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4446543&req=5

fig6: Plots of remaining FA concentration versus time for zero order (a), first order (b), and second order (c) equations.
Mentions: Regarding the presence of degradation products, forced degradation study showed different results depending on the stress condition used. After exposure to acid medium, approximately 29.37% of FA was degraded (Figure 5(a)) and the drug peak was recorded at 4.56 min. In alkaline condition, a FA degradation of 16.33% was observed and the drug peak was detected at 4.55 min (Figure 5(b)). No previous report was devoted to investigate the drug degradation using 0.1 M HCl and 0.1 M NaOH. Under photolytic conditions, decreases in FA concentration from methanol solution were observed (Figure 6). On the other side, the cuvette covered by aluminum paper showed no degradation after 6 h which indicates that no thermal degradation was involved in the photodegradation process. Moreover, no additional peak was verified in the chromatograms of the forced degradation study demonstrating that the degradation products were not detected using the optimized chromatographic conditions.

Bottom Line: The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of quantification, limit of detection, accuracy, precision, and robustness provided suitable results regarding all parameters investigated.Precision (intraday and interday) was demonstrated by a relative standard deviation lower than 2.0%.In conclusion, the method is suitable to be applied to assay FA as bulk drug and into polymeric microparticles and can be used for studying its stability and degradation kinetics.

View Article: PubMed Central - PubMed

Affiliation: Postgraduate Program in Pharmaceutical Sciences, Department of Pharmacy, Federal University of Paraná, 632 Lothário Meissner Avenue, 80210-170 Curitiba, PR, Brazil.

ABSTRACT
A simple stability-indicating HPLC-DAD method was validated for the determination of ferulic acid (FA) in polymeric microparticles. Chromatographic conditions consisted of a RP C18 column (250 mm × 4.60 mm, 5 μm, 110 Å) using a mixture of methanol and water pH 3.0 (48 : 52 v/v) as mobile phase at a flow rate of 1.0 mL/min with UV detection at 320 nm. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of quantification, limit of detection, accuracy, precision, and robustness provided suitable results regarding all parameters investigated. The calibration curve was linear in the concentration range of 10.0-70.0 μg/mL with a correlation coefficient >0.999. Precision (intraday and interday) was demonstrated by a relative standard deviation lower than 2.0%. Accuracy was assessed by the recovery test of FA from polymeric microparticles (99.02% to 100.73%). Specificity showed no interference from the components of polymeric microparticles or from the degradation products derived from acidic, basic, and photolytic conditions. In conclusion, the method is suitable to be applied to assay FA as bulk drug and into polymeric microparticles and can be used for studying its stability and degradation kinetics.

No MeSH data available.


Related in: MedlinePlus